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MiMedx Group, Inc. (MDXG)

Q1 2018 Earnings Call· Fri, Apr 27, 2018

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Transcript

Executives

Management

Robert Borchert - VP, Investor Relations Bill Taylor - Chief Operating Officer Michael Senken - Chief Financial Officer Christopher Cashman - Executive Vice President and Chief Commercialization Officer Deborah Dean - Executive Vice Presidents. Pete Petit - Chairman & CEO

Operator

Operator

Good day ladies and gentlemen, and welcome to the Q1 MiMedx Shareholder Conference Call. At this time, all participants are in a listen-mode. [Operator Instructions] As a reminder, this call is being recorded. I would now like to introduce Robert Borchert, Vice President, Investor Relations. Sir, you may begin.

Robert Borchert

Analyst

Thank you, Heather, and good morning everyone. I like to remind you that our comments today may include forward-looking statements that are subject to risk and uncertainty and actual results could differ materially. We list the factors that might cause the actual results to differ materially in our filings with the Securities and Exchange Commission, which are available on our website, midedx.com. We do not undertake to update or revise any forward-looking statement except as maybe required by the company's disclosure obligations in filings it makes with the SEC under Federal Securities Laws. Finally, MiMedx is not responsible for the accuracy of our telecast conference transcripts provided by third parties. The only authorized live and archived webcasts are located on our website. Now I will turn the call over to MiMedx’s Chairman and CEO, Pete Petit.

Pete Petit

Analyst

Thank you, Robert. Good morning. We appreciate you joining us for this quarterly update. I have with me Bill Taylor, our present Chief Operating Officer; Mike Senken, our Chief Financial Officer; Chris Cashman, our Executive Vice President and Chief Commercialization Officer; and Debby Dean, one of our Executive Vice Presidents who has wide responsibilities. First please refer to our December 13, 2017 press release for our 2018 financial guidance. Given the investigation by our audit committee, we cannot release the specifics of our financials yet. However, we can give you sufficient information to assist you in understanding how excellent our first quarter was. For the first quarter, we exceeded the top-end of our revenue guidance nicely. Recall that our top-end revenue guidance was $92 million. Also our distributor and OEM revenue was less than 5% of our total revenue. That is the way it has been for a number of quarters now. Our cash flow for the quarter was strong and we are tracking to or exceeding our annual goals on gross margin of 89% to 90%; operating income of 15% to 17%, as well as fully diluted GAAP EPS of 30% to 35%, and adjusted EPS of $0.45 to $0.50. Refer to the December 13th press release for more details on those particular items if necessary. We are also increasing our 2018 revenue guidance and providing guidance on our second quarter. We had previously communicated revenue guidance in that press release for 2018 of $383 million to $387 million. We are increasing our revenue guidance range to $389 million to $394 million because of our performance in the first quarter, and of course, anticipated performance throughout the year. In regard to the second quarter, that revenue is now expected to be $96 million to $98 million. We had what I consider to be an excellent quarter. Operationally we are continuing to improve our manufacturing processes, which now include the use of lasers for cutting and perforating. That could further enhance our gross profit margins. Additionally, all of our functional areas performed very well. The efficiency and effectiveness resulting from the implementation of a new sales management system is proving to be an extremely effective asset, and we will continue to make a substantial difference in our ability to accomplish our sales planning and execution in quarters and years ahead. We now have over 400 dedicated sales representatives and that group is growing rapidly. I'm going to turn the meeting over to Bill, and I will have some further comments later.

Bill Taylor

Analyst

Thanks Pete. Good morning everyone. Our first quarter 2018 was operationally one of the best first quarters in the past several years. As most people will recall, the first calendar quarter tends to be the softest quarter of each year for many reasons. This year we overcame the normal insurance deductible resets, a challenging winter that just seemed never to stop, as well as the external noise from our current situation. With all these factors in play, our team stayed focused and performed extremely well. For that continued performance and focus I thank each and every member of the MiMedx team. MiMedx is keenly focused on serving clinicians and the patients they treat. We also continue to be very focused on expanding our sales footprint and further penetrating each of the markets we serve. We are managing our territories with a diligent four to six quarters out and this continues to help our predictability and our ability to forecast with good accuracy. In our February call, I mentioned that we had reached 400 sales personnel earlier this year, which was up from 350 in September of last year. Today, when including recently accepted offers, we are at about 425 with plans to get to 450 field sales personnel by the third quarter. This puts us slightly ahead of our previously discussed pace. Our detailed planning and territory management discipline, education, execution and accountability particularly through the use of our sales management system or SMS continues to drive predictable and sustainable results. The other areas of our operations are also performing quite well. We are expanding our research and development organization, and continue to add personnel who have experience with biologics and other more complex regulatory paths. We are looking at our five year plus strategic plan to evaluate how we…

Christopher Cashman

Analyst

Thanks, Bill and good morning. First I want to thank our whole team for the diligence and hard work that they each exhibited in pursuit of outstanding performance. The first quarter is always our toughest quarter of the year and everyone buckled down and worked the sales management system business plan that they each formulated with management. We are energized by our continued progress in our markets, and are continuing to hire within the sales organization and support groups. As Bill noted, we expect to continue hiring beyond our budgeted 450 sales personnel by year-end in order to meet our growth plans and to further access the market opportunities. As we are well into the second quarter, I want to address the importance of our product and specialty initiatives. It is paramount that we continue to focus first and foremost on our core wound care products. As a recognized leader, it is critical for MiMedx to continue to gain market share as well as drive market expansion. Our competition is trying to lead with price and say their products perform the same, even though there is no level 1 clinical data to support those claims. We continue to be successful in communicating and educating physicians on our safety profile and efficacy as well as the importance of processing, quality and consistency as exhibited by our US pharmacopeia mark and compliance to good manufacturing practices. Our MiMedx representatives are focused on being a part of making a difference in patients’ lives. We continue to invest in medical education and peer-to-peer symposiums. Once providers have experienced the power of healing that resides with MiMedx’s product offerings and wound healing then they begin to expand their applications into foot and ankle pain and lower extremity and complex wound and surgical procedures. MiMedx is…

Deborah Dean

Analyst

Thanks Chris. Good morning. Today I would like to start by updating you on our IND trials and RMAT designation. As you might remember, we are currently running four IND or investigational new drug trials as we progress towards the filing of biological license applications with the Food and Drug Administration for micronized dHACM or AmnioFix injectable to treat certain musculoskeletal pain management indications. We currently have our manuscript for the primary endpoint measurements for our plantar fasciitis Phase 2b trial under review. We hope that it can be published in the next 60 days. Once this study is published, we plan to submit to [payers] for coverage determination. This product has proven repeatedly to be highly efficacious. At the three month follow-up visit, mean VAS, visual analog scale scores for pain in the treatment of the group were 76% lower compared with a 45% reduction in mean VAS scores for control, which equates to a 54 point drop in the treatment group versus a 32 point drop in the control group, or a p-value of less than 0.0001. Additionally subject to receive, the micronized dHACM injection had a mean reduction of 60% in the FFIR foot function index score compared to baseline, which subject to receiving [placebo] had a mean reduction of 40% in FFIR score at 3 months compared to baseline, which equates to 36 point drop in treatment group and a 22 point drop in the control group with a p-value of 0.0004. Enrolment in our two Phase 3 clinical trials for plantar fasciitis and Achilles tendinitis are going very well. Currently we anticipate the plantar fasciitis trial will finish prior to the AT trial but they are both ramping nicely. Our Phase 2-b trial for treatment of knee pain due to osteoarthritis started enrolment in late…

Pete Petit

Analyst

Thank you, Debby. Obviously we continue to relentlessly execute on our business strategy. We continue to fulfil commitments made to you, our shareholders. We continue to fulfil commitments made to our patients and to our scientific and clinical endeavours. We continue to build assets of this business in a very routine and programmed manner. Our cash flow is strong and is expected to continue to build. In fact, I believe you will see a significant build-up of our cash in the second quarter, which is generally the way the business has been run for years. I will remind you that the company has no debt and sees no need for debt financing at this point. Recall that we have repurchased over $130 million of our stock in the last 3.5 years. That cash came from our strong earnings and resulting cash flow. The company is currently very undervalued in my opinion. There is another company I will mention that has gross profit margins and growth rates of approximately the same as ours in the healthcare area. That company’s name is [Abiomed]. The company is currently trading at approximately 22 times this year's revenue. I will say that again, 22 times this year's revenue. MiMedx is currently trading at about 2.3 times this year's revenue. I would say this is clearly demonstrate – a demonstration of an undervalued situation on our part. At some point the audit committee of our board will complete its investigation and we will then publish our audited 2017 financial statements and our reviewed first quarter financial statements. It is management's opinion that your company has a very bright future ahead as we continue to grow in the advanced wound care sector of healthcare, and now very importantly brings new therapies to the market through our FDA BLA IND processes. I want to thank our investors who have been patient enough to retain their stock ownership in the company during the time. We want to make it clear that companies continue to perform operations like we have over the years, which led MiMedx to become the fifth fastest public growing company in America according to Fortune magazine. Finally, I want to thank our employees and the board of directors for their dedication and ongoing commitment. We thank you for listening today. We look forward to speaking with you again in the near future about some new opportunities. On that call we open it up for questions. Thank you very, very much. End of Q&A: Ladies and gentlemen thank you for participating in today’s conference. This does conclude the program and you all may disconnect. Everyone have a wonderful day.